NCT07145450 Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC
| NCT ID | NCT07145450 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Anocca AB |
| Condition | PDAC |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2030-04-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 96 participants in total. It began in 2025-07-03 with a primary completion date of 2030-04-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open-label, multi-centre, single-arm Phase 1/2 clinical trial of the safety, expansion, persistence and clinical activity of a set of engineered autologous T cells products each capable of recognizing a specific combination mutated KRAS and HLA, activating the T cells and exerting anti- tumour activity in patients with metastatic or locally advanced PDAC.
Eligibility Criteria
Inclusion Criteria: 1. Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease. 2. HLA genotyping confirmed with a high-resolution method. 3. Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample. 4. Fertile male and female patients must use a highly effective contraceptive method before, during, and for at least 6 months after the last mutKRAS TCR infusion. Acceptable contraception for women includes implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for male includes having had a vasectomy for at least 6 months, sexual abstinence, to condoms plus spermicide. Fertile female and male patients must adhere to any treatment-specific pregnancy prevention guidelines for cyclophosphamide (refer to SmPC). 5. Confirmed clinical benefit to SoC treatments and absence of disease progression according to the PI judgement. 6. Measurable disease by RECIST 1.1 criteria at the time of first treatment. Baseline imaging (for example, diagnostic CT chest/abdomen/pelvis and imaging of the affected extremity or brain, as appropriate), magnetic resonance imaging (MRI or CT scan) must be obtained within 8 weeks of the first planned T cell infusion. CT can be substituted for MRI in patients unable to have CT contrast. Exclusion Criteria: 1. Another malignancy other than PDAC. 2. Current or history of brain metastasis. 3. Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07145450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PDAC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07145450 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07145450 currently recruiting?
Yes, NCT07145450 is actively recruiting participants. Contact the research team at sheila.forsman@anocca.com for enrollment information.
Where is the NCT07145450 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Berlin, Germany, Dresden, Germany, Heidelberg, Germany and 4 additional locations.
Who is sponsoring the NCT07145450 clinical trial?
NCT07145450 is sponsored by Anocca AB. The trial plans to enroll 96 participants.